GEMFIBROZIL
gemfibrozil
CAS: 25812-30-0
Molecular Formula: C15H22O3
GEMFIBROZIL - Names and Identifiers
GEMFIBROZIL - Physico-chemical Properties
| Molecular Formula | C15H22O3 |
| Molar Mass | 250.33 |
| Density | 1.1109 (rough estimate) |
| Melting Point | 61-63°C |
| Boling Point | 158-159 C |
| Flash Point | 141.6°C |
| Water Solubility | >0.5g/L(temperature not stated) |
| Solubility | Soluble in DMSO (50 mg/ml at 25 °C), water (<1 mg/ml at 25 °C), ethanol (50 mg/ml a |
| Vapor Presure | 6.13E-07mmHg at 25°C |
| Appearance | powder |
| Color | White to Off-White |
| Merck | 14,4388 |
| pKa | 4.75±0.45(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5020 (estimate) |
| MDL | MFCD00079335 |
| Physical and Chemical Properties | Crystallized from hexane, melting point 61-63 ℃, boiling point 158~159 ℃/2.67Pa. Acute toxic LD50 mice, rats (mg/kg):3162,4786 oral. |
| Use | Blood Lipid regulating drug, can reduce blood cholesterol and triglyceride content |
GEMFIBROZIL - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R63 - Possible risk of harm to the unborn child R62 - Possible risk of impaired fertility R46 - May cause heritable genetic damage R36/38 - Irritating to eyes and skin. R21 - Harmful in contact with skin |
| Safety Description | S36 - Wear suitable protective clothing. S53 - Avoid exposure - obtain special instructions before use. S36/37 - Wear suitable protective clothing and gloves. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S25 - Avoid contact with eyes. |
| WGK Germany | 3 |
| RTECS | YV7120000 |
| HS Code | 2918992090 |
| Hazard Class | IRRITANT |
| Toxicity | LD50 in mice, rats (mg/kg): 3162, 4786 orally (Kurtz) |
GEMFIBROZIL - Nature
Open Data Verified Data
white crystalline powder, odorless, tasteless. Melting Point 61~63 ℃; bpo. 02 158~159 ℃, very soluble in chloroform, soluble in methanol, ethanol, acetone or hexane, insoluble in water; Soluble in sodium hydroxide solution.
Last Update：2024-01-02 23:10:35
GEMFIBROZIL - Preparation Method
Open Data Verified Data
2, 5-methylphenol is reacted with 1,3 dibromopropane to form 3-(2,5 dimethylphenoxy) propyl bromide. Isobutyric acid, magnesium oxide and toluene are mixed and stirred, and heated to reflux to obtain a concentrated solution containing magnesium isobutyrate. A tetrahydrofuran solution of diisopropylamine and a pentane solution of n-butyl lithium are added thereto, and appropriate conditions are controlled, the resulting 3-(2.5-dimethylphenoxy) propyl bromide was added, and the reaction was stirred at room temperature and treated to give gemfibrozil. Alternatively, isobutyl isobutyrate reacts with 1 monochloro-3-bromopropane under the action of lithium diisopropylamide to form 5 monochloro-2, 2-methylpentanoate isobutyl Ester, and then reacts with 2,5-= methylphenol, gemfibrozil was obtained by hydrolysis.
Last Update：2022-01-01 09:10:55
GEMFIBROZIL - Standard
Authoritative Data Verified Data
This product is 2, 2-dimethyl-5-(2, 5-xylyloxy)-pentanoic acid. The content of C15H2203 shall be between 98.0% and 102.0% based on the anhydrous content.
Last Update：2024-01-02 23:10:35
GEMFIBROZIL - Trait
Authoritative Data Verified Data
- This product is white crystalline powder; Odorless.
- This product is easily soluble in chloroform, soluble in methanol, ethanol, propane or hexane, insoluble in water; Soluble in sodium hydroxide solution.
melting point
The melting point of this product (General 0612) is 58~61°C.
Last Update：2022-01-01 11:43:22
GEMFIBROZIL - Use
Open Data Verified Data
It was first launched in the United States in February 1982. It is a kind of lipid regulator, which can significantly reduce the content of triglyceride and cholesterol in blood, and can significantly reduce the very low density lipoprotein (VLDL). Increased high-density lipoprotein (HDL), but had little effect on low-density lipoprotein. For hyperlipidemia. Suitable for severe Type IV or V type hyperlipoproteinemia, coronary heart disease risk and diet control, weight loss and other treatment ineffective. It is also suitable for patients with type Ⅱ B Hyperlipoproteinemia, high risk of coronary heart disease and diet control, weight loss, and ineffective treatment with other blood lipid regulating drugs.
Last Update：2022-01-01 09:10:56
GEMFIBROZIL - Differential diagnosis
Authoritative Data Verified Data
- take about 50mg of this product, add 3ml of ethanol, dissolve, Take 5 drops of solution, add 2 drops of 2% potassium iodide solution and 2 drops of 4% potassium iodate solution, and heat in water bath for 1 min, after cooling, 2 drops of starch indicator solution were added, which showed blue color.
- in the chromatogram under the content determination, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 601).
Last Update：2022-01-01 11:43:23
GEMFIBROZIL - Safety
Open Data Verified Data
mouse, rat oral LDso (mg]kg): 3162,4786.
Last Update：2022-01-01 09:10:56
GEMFIBROZIL - Exam
Authoritative Data Verified Data
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 10mg per 1ml, as a test solution; Take an appropriate amount of precision, A solution containing about 20ug per 1ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, take 10ul of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.2%), the sum of each impurity peak area shall not be greater than 5 times (1.0%) of the main peak area of the control solution.
residual solvent
take about 0.2g of this product, weigh it accurately, put it in a 20ml headspace bottle, add 5ml of dimethyl sulfoxide with precision, shake to dissolve it, seal it, and use it as a test solution; in addition, ethyl formate, n-hexane, Tetrahydrofuran, methylcyclohexane and toluene were appropriately weighed and diluted quantitatively with dimethyl sulfoxide to make 200ug, 11.6ug, 28.8ug and, the mixed solution of 47.2UG and 35.5UG, 5ml is accurately measured, placed in a 20ml headspace bottle, sealed, and used as a reference solution. Test as residual solvent assay (General 0861 second method). With 100% dimethyl polysiloxane (or polar similar) as the fixing liquid; The initial temperature is 40°C, maintained for 7 minutes, and the temperature is raised to 200°C at a rate of 15°C per minute for 5 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 80°C and the equilibrium time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks of each component shall meet the requirements. Then the sample solution and the reference solution were injected with headspace, and the chromatogram was recorded. According to the external standard method, the residual amount of ethyl formate, n-hexane, Tetrahydrofuran, methylcyclohexane and toluene shall be in accordance with the regulations.
moisture
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 0.25%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 11:43:24
GEMFIBROZIL - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water-glacial acetic acid (75:24:1) was used as the mobile phase; The detection wavelength was 276nm. Appropriate amount of gemfibrozil reference substance and 2, 5-dimethylphenol (impurity I) were dissolved and diluted with mobile phase to prepare solutions containing about 0.2mg and 0.05mg respectively per 1 ml, and 10 u1 was taken, injected into the liquid chromatograph, the separation degree of gemfibrozil peak and impurity I peak shall meet the requirements, and the number of theoretical plates shall not be less than 1500 based on gemfibrozil peak.
assay
take an appropriate amount of this product, precision weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.2mg per lml, as a test solution, take 10 u1 for precision measurement, injection liquid chromatograph, record chromatogram. Another gemfibrozil reference substance was used for precision weighing and determination by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:43:24
GEMFIBROZIL - Category
Authoritative Data Verified Data
hypolipidemic drugs.
Last Update：2022-01-01 11:43:25
GEMFIBROZIL - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:43:25
GEMFIBROZIL - Gemfibrozil Capsules
Authoritative Data Verified Data
This product contains gemfibrozil (C15H2203) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white powder.
identification
- take an appropriate amount of the content of this product (about 60mg equivalent to gemfibrozil), add 3ml of ethanol to dissolve gemfibrozil, filter, and show the same reaction according to the identification (1) Test under the item of gemfibrozil.
- in the chromatogram under the content determination, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the contents of this product (about equivalent to gemfibrozil lOOmg), plus 0.1 mol/L sodium hydroxide solution 10ml to dissolve gemfibrozil, filtered, filtrate in centrifuge tube, acidified with dilute sulfuric acid, precipitate, centrifugal, discard the supernatant, precipitate with a small amount of water washing, vacuum filtration, it was dried in a silica gel dryer for 12 hours. The infrared absorption pattern should be consistent with that of the control (Spectrum set 601).
examination
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), phosphate buffer (pH7.5) (take potassium dihydrogen phosphate 27.22g and sodium hydroxide 5.52g, add water to dissolve 1000ml, adjust the pH value to 7.5, shake well) 900ml as the dissolution medium, the rotation speed is 50 rpm, operate according to law, after 45 minutes, take the solution and filter, the appropriate amount of continued filtrate was accurately taken and quantitatively diluted with lmol/L sodium oxyhydroxide solution to prepare a solution containing about 70ug of gemfibrozil per lml as the test solution, 1 mol/L sodium hydroxide solution was added to dissolve and quantitatively dilute to prepare a solution containing 70mg per 1 ml as a control solution. The absorbance of each of the above two Solutions was measured at a wavelength of 0401 nm by ultraviolet-visible spectrophotometry (general), and the elution amount of each particle was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix well, accurately weigh an appropriate amount (about 50mg equivalent to gemfibrozil), put it in a 50ml measuring flask, and add an appropriate amount of mobile phase under the determination of gemfibrozil content, shake to dissolve gemfibrozil, dilute to scale with mobile phase, shake well, filter, Take 5ml of continuous filtrate precisely, put it in a 25ml measuring flask, dilute to scale with mobile phase, shake well, as the test solution, according to the method under the item of gemfibrozil content determination, that is obtained.
category
Same as gemfibrozil.
specification
(1)0.15g (2)0.3g
storage
sealed and stored in a cool and dry place.
Last Update：2022-01-01 11:43:26
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CAS: 25812-30-0
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Tel: +86-18821248368
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View History
GEMFIBROZIL
倍他米松 17-丙酸盐-D5
水合六氰合铁(II)酸铁(III)铵
吴茱萸次碱, 来源于吴茱萸
氧化锌水合物
3-(2-溴苯基)-1-丙醇
7,9-二甲基鸟嘌呤
(大包装采购-CP)3-碘氧杂环丁烷
9, 10-Anthracenedione, 1, 5-dihydroxy-4, 8-bis(methylamino)
2-甲基肉桂醛
倍他米松 17-丙酸盐-D5
水合六氰合铁(II)酸铁(III)铵
吴茱萸次碱, 来源于吴茱萸
氧化锌水合物
3-(2-溴苯基)-1-丙醇
7,9-二甲基鸟嘌呤
(大包装采购-CP)3-碘氧杂环丁烷
9, 10-Anthracenedione, 1, 5-dihydroxy-4, 8-bis(methylamino)
2-甲基肉桂醛